Model AA-8565CV-ACTModel AA-8565CV

Model AA-8565CV-ACT Model AA-8565CV by

Drug Labeling and Warnings

Model AA-8565CV-ACT Model AA-8565CV by is a Other medication manufactured, distributed, or labeled by Aerospace Accessory Service, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MODEL AA-8565CV-ACT MODEL AA-8565CV- emergency response safety kit   
Aerospace Accessory Service, Inc

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Model AA-8565CV-ACT
Model AA-8565CV

Aerospace Accessory Service

Aerospace Accessory Service

P/N:

S/N:

EXP:

Prep. By: 

Label

MODEL AA-8565CV-ACT MODEL AA-8565CV 
emergency response safety kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:27860-013
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:27860-013-161 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 2
Part 3
Part 4
Part 5
Part 6
Part 7
Part 8
Part 9
Part 10
Part 11
Part 12
Part 13
Part 14
Part 15
Part 16
Part 17
Part 18
Part 19
Part 20
Part 21
Part 22
Part 23
Part 24
Part 25
Part 26
Part 27
Part 28
Part 29
Part 1 of 29
SODIUM CHLORIDE 
sodium chloride injection, solution
Product Information
Item Code (Source)NDC: 0338-0049
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE9 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01667712/09/1970
Part 2 of 29
SODIUM CHLORIDE 
sodium chloride injection, solution
Product Information
Item Code (Source)NDC: 0264-7800
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01963503/09/1988
Part 3 of 29
ATROPINE SULFATE 
atropine sulfate injection, solution
Product Information
Item Code (Source)NDC: 0409-4910
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ENDOTRACHEAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SULFURIC ACID (UNII: O40UQP6WCF)  
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02114601/19/2006
Part 4 of 29
ATROPINE SULFATE 
atropine sulfate injection
Product Information
Item Code (Source)NDC: 76329-3339
Route of AdministrationPARENTERAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atropine Sulfate (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) Atropine Sulfate0.1 mg  in 1 mL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2000
Part 5 of 29
DEXTROSE MONOHYDRATE 
dextrose monohydrate injection
Product Information
Item Code (Source)NDC: 76329-3301
Route of AdministrationPARENTERAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE500 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2000
Part 6 of 29
DEXTROSE 
dextrose monohydrate injection, solution
Product Information
Item Code (Source)NDC: 0409-6648
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE25 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01944512/02/2005
Part 7 of 29
NITROGLYCERIN 
nitroglycerin tablet
Product Information
Item Code (Source)NDC: 68462-639
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN0.4 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
Product Characteristics
Colorwhite (white to off white) Scoreno score
ShapeROUND (Flat faced) Size4mm
FlavorImprint Code 2;C
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20639108/19/2017
Part 8 of 29
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride injection
Product Information
Item Code (Source)NDC: 0641-0376
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08081711/27/1972
Part 9 of 29
EPINEPHRINE 
epinephrine injection, solution, concentrate
Product Information
Item Code (Source)NDC: 54288-103
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) Epinephrine1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride (UNII: 451W47IQ8X)  
Hydrochloric Acid (UNII: QTT17582CB)  
Water (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20502908/08/2014
Part 10 of 29
ALCOHOL PREP 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC: 67777-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00307/01/2010
Part 11 of 29
MOORE MEDICAL NON ASPIRIN 
acetaminophen tablet, film coated
Product Information
Item Code (Source)NDC: 55670-467
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code AZ;234
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/30/2008
Part 12 of 29
ASPIRIN 
aspirin tablet, film coated
Product Information
Item Code (Source)NDC: 55670-131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MINERAL OIL (UNII: T5L8T28FGP)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code TCL;011
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/30/200808/31/2022
Part 13 of 29
VENTOLIN  HFA
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC: 0173-0682
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE (UNII: DH9E53K1Y8)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02098306/09/2006
Part 14 of 29
ALBUTEROL SULFATE  HFA
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC: 66993-019
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE (UNII: DH9E53K1Y8)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02098301/15/2019
Part 15 of 29
ALBUTEROL SULFATE 
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC: 45802-088
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
NORFLURANE (UNII: DH9E53K1Y8)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20376002/26/2020
Part 16 of 29
ALBUTEROL SULFATE  HFA
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC: 0093-3174
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE (UNII: DH9E53K1Y8)  
ALCOHOL (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02145701/16/2019
Part 17 of 29
ALBUTEROL SULFATE 
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC: 0254-1007
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL108 ug
Inactive Ingredients
Ingredient NameStrength
OLEIC ACID (UNII: 2UMI9U37CP)  
NORFLURANE (UNII: DH9E53K1Y8)  
ALCOHOL (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02050304/03/2019
Part 18 of 29
PROAIR  HFA
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC: 59310-579
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE (UNII: DH9E53K1Y8)  
ALCOHOL (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02145712/03/2012
Part 19 of 29
POVIDONE-IODINE 
povidone-iodine solution
Product Information
Item Code (Source)NDC: 46414-7777
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/14/1976
Part 20 of 29
BZK PADS 
benzalkonium chloride swab
Product Information
Item Code (Source)NDC: 67777-245
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00304/05/2011
Part 21 of 29
SOLU-CORTEF 
hydrocortisone sodium succinate injection, powder, for solution
Product Information
Item Code (Source)NDC: 0009-0825
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE SODIUM SUCCINATE (UNII: 50LQB69S1Z) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE100 mg  in 2 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00986604/27/1955
Part 22 of 29
SOLU-CORTEF 
hydrocortisone sodium succinate injection, powder, for solution
Product Information
Item Code (Source)NDC: 0009-0011
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE SODIUM SUCCINATE (UNII: 50LQB69S1Z) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE100 mg  in 2 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00986604/27/1955
Part 23 of 29
FUROSEMIDE 
furosemide injection, solution
Product Information
Item Code (Source)NDC: 23155-473
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5) FUROSEMIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20342809/02/2014
Part 24 of 29
FUROSEMIDE 
furosemide injection, solution
Product Information
Item Code (Source)NDC: 63323-280
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5) FUROSEMIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01890207/12/2000
Part 25 of 29
FUROSEMIDE 
furosemide injection, solution
Product Information
Item Code (Source)NDC: 36000-283
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5) FUROSEMIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20274702/06/2014
Part 26 of 29
PITOCIN 
oxytocin injection
Product Information
Item Code (Source)NDC: 42023-116
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN10 [iU]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID (UNII: Q40Q9N063P)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01826102/01/2008
Part 27 of 29
OXYTOCIN 
oxytocin injection, solution
Product Information
Item Code (Source)NDC: 63323-012
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN10 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID (UNII: Q40Q9N063P)  
CHLOROBUTANOL (UNII: HM4YQM8WRC)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01824808/10/2000
Part 28 of 29
PROMETHAZINE HYDROCHLORIDE 
promethazine hydrochloride injection
Product Information
Item Code (Source)NDC: 0641-1495
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PHENOL (UNII: 339NCG44TV)  
ACETIC ACID (UNII: Q40Q9N063P)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08331209/19/1973
Part 29 of 29
METOPROLOL TARTRATE 
metoprolol tartrate tablet, film coated
Product Information
Item Code (Source)NDC: 65862-062
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23) METOPROLOL TARTRATE25 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code C;73
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07773909/11/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceABC01/01/201510/25/2024
Labeler - Aerospace Accessory Service, Inc (859100547)
Registrant - Aerospace Accessory Service, Inc (859100547)
Establishment
NameAddressID/FEIBusiness Operations
Aerospace Accessory Service, Inc859100547repack

Revised: 10/2024